Cryoneurolysis in Anterior Cruciate Ligament Reconstruction (ACLR)

NCT07731178 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 25-00771
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to assess whether cryoneurolysis will help control pain after ACLR surgery and decrease the need of opioid medications. The primary objective is to compare postoperative functional recovery between Iovera and sham arms at 1 month after ACLR.

Conditions

ACL Reconstruction (ACLR) With a Bone-patellar Tendon-bone (BPTB) Autograft

Keywords

ACLR

Outcome Measures

Primary Outcomes (2)

• Difference in Knee Injury and Osteoarthritis Outcome Score (KOOS)

  The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.

  Baseline, 1 Month

• Difference in Lysholm knee scoring scale (LKSS)

  The Lysholm knee scoring scale is a 100-point patient-reported questionnaire designed to assess functional knee ligament injuries. It evaluates eight areas - limp, support, locking, instability, pain, swelling, stair climbing, and squatting - with higher scores (up to 100) indicating better function.

  Baseline, 1 Month

Secondary Outcomes (7)

• Change in Visual Analogue Scale (VAS) for Pain score

  Baseline, Post-operative Day 1

• Change in Visual Analogue Scale (VAS) for Pain score

  Baseline, Week 3

• Change in Visual Analogue Scale (VAS) for Pain score

  Baseline, Month 6

• Change in Numeric Rating Scale (NRS)

  Baseline, Post-operative Day 1

• Change in Numeric Rating Scale (NRS)

  Baseline, Week 3

Study Arms (2)

Ioveraº cryoneurolysis study group

EXPERIMENTAL

Participants will receive the ioveraº cryoneurolysis intervention before surgery.

Device: Pacira Iovera Cryoneurolysis device

Placebo study group

SHAM COMPARATOR

Participants will have a sham intervention that does not have cryoneurolysis before surgery.

Device: Placebo/Sham device

Interventions

Pacira Iovera Cryoneurolysis device DEVICE

The device includes a hand-held piece, charging port with cord, and disposable components: the nitrous oxide capsule and a small probe called the Smart Tip, which has needles that administer the cold to the nerve. It works immediately by freezing nerves that transmit pain signals to reduce pain transmission after surgery.

Ioveraº cryoneurolysis study group

Placebo/Sham device DEVICE

The placebo/sham device looks just like the ioveraº device, but does not contain cyoneurolysis or any treatment.

Placebo study group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-45 years
• Scheduled for primary ACLR with BPTB autograft
• Willingness and ability to participate in Iovera
• No chronic opioid use preoperatively
• No known neurologic disorders affecting the lower extremity
• Capacity and willingness to provide informed consent and comply with follow-up schedules

You may not qualify if:

• Prior surgery on the affected knee.
• Non-English speaking if validated PRO instruments at the site are only available in English; include validated translations if available and approved.
• Contraindications to cryoneurolysis (e.g., cryoglobulinemia, cold urticaria, Raynaud's phenomenon, paroxysmal cold hemoglobinuria) or to local anesthetics.
• Active skin infection, dermatitis, or compromised skin integrity at or near treatment sites.
• Bleeding diathesis or anticoagulant therapy not compatible with minor percutaneous procedures per institutional policy.
• Pregnancy or breastfeeding.
• Known peripheral neuropathy or significant sensory deficit of the target region.
• Any condition that, in the investigator's judgment, increases risk or interferes with participation
• Concomitant use of other opioid drugs or prior chronic use.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Study Officials

• Eric J. Strauss, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Layne Estes

CONTACT

646-501-7208; Layne.estes@nyulangone.org

Eric J. Strauss, MD

CONTACT

646-501-7208; Eric.strauss@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)